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usp-1079-good-storage-and-shipping-practices-for-drug-products
Pharmacopoeia-Based Assays BP Appendix VIII G: Total Ash in Herbal ProductsBP Appendix X: Identification Tests for Organic CompoundsBP Appendix XI C: Test for Water Insoluble MatterBP Appendix XII C: Uniformity of Weight TestBP Appendix XII F: Microbial Limits for Cosmetic PreparationsBP Appendix XII G: Total Aerobic Microbial Count in LiquidsBP Appendix XIV A: Refractive Index Measurement for OilsBP Appendix XIV C: Determination of pH Using ElectrodesBP Appendix XIV F: Assay of Sulphates by GravimetryBP Appendix XV B: Assay of Chloride in Raw MaterialsEP 2.2.2 UV-Visible Spectrophotometry AssayEP 2.2.20 Thin-Layer Chromatography Identity TestingEP 2.2.24 Absorption Spectrophotometry in the IR RegionEP 2.2.28 Gas Chromatography Method ValidationEP 2.2.3 Potentiometric pH MeasurementEP 2.2.32 Loss on Drying DeterminationEP 2.2.38 Differential Scanning Calorimetry AssayEP 2.4.4 Sulphated Ash for ExcipientsEP 2.4.8 Sulphated Ash AnalysisEP 2.5.12 Water Content (Karl Fischer Method)EP 2.6.12 Microbiological Examination of Non-Sterile ProductsEP 2.6.14 Microbiological Integrity Testing for PackagingEP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor CEP 2.9.1 Uniformity of Mass for Single-Dose PreparationsEP 2.9.3 Friability Testing for Uncoated TabletsEP 2.9.5 Hardness of Tablets MeasurementEP 2.9.7 Dissolution Testing for Gastro-resistant TabletsJP 3.01 Uniformity of Content in Powdered DrugsJP 3.03 Color and Clarity of Solution TestingJP 3.05 Osmolarity Testing in Ophthalmic SolutionsJP 4.01 Identification of Active Pharmaceutical IngredientsJP 4.04 Assay of Active Compounds Using UV MethodJP 4.05 Water Determination in Raw MaterialsJP 5.02 Determination of Peroxides in Lipophilic CompoundsJP 6.01 Test for Related Substances Using HPLCJP 6.03 Dissolution Test for Capsule Dosage FormsJP 6.04 Analysis of Pesticide Residues in Herbal MedicinesJP 6.05 Testing for Insoluble Matter in InjectionsJP 7.01 Test for pH in Oral SolutionsJP 7.02 Heavy Metal Test for Injection ProductsJP 8.02 Identity Testing Using IR SpectroscopyJP 8.03 Residual Solvents in APIsJP 9.01 Chromatographic Purity for Active SubstancesJP 9.04 Microbial Limits Test for OintmentsUSP <1029> Good Documentation Practices for TestingUSP <1030> Biological Assay for AntibodiesUSP <1032> Design and Conduct of Bioavailability StudiesUSP <1039> Reduced Sampling and Testing Plan JustificationUSP <1047> Testing for Biotechnological Protein ProductsUSP <1058> Analytical Instrument QualificationUSP <1062> Tablet and Capsule Weight Variation StudyUSP <1078> Good Manufacturing Practices for Bulk ExcipientsUSP <1088> Stability Testing of Drug SubstancesUSP <1092> Tablet Coating Performance TestingUSP <1106> Whole Package Integrity TestingUSP <1111> Microbiological Quality of Nonsterile ProductsUSP <1116> Control of Bioburden in Clean RoomsUSP <1117> Best Practices for Handling Hazardous CompoundsUSP <1163> Quality Assurance in Pharmaceutical CompoundingUSP <1181> Evaluation of Stability-Indicating MethodsUSP <1191> Stability Testing for Compounded PreparationsUSP <1216> Tablet Friability TestingUSP <121> Sterilization Assurance Level TestingUSP <1224> Transfer of Analytical ProceduresUSP <1225> Validation of Analytical ProceduresUSP <1226> Verification of Compendial ProceduresUSP <1227> Validation of Microbial Recovery from Pharm WatersUSP <1228> Depyrogenation Validation of EquipmentUSP <1231> Water for Pharmaceutical Purposes TestingUSP <231> Heavy Metals Limit Test for PharmaceuticalsUSP <232> Elemental Impurities – Limits in Finished ProductsUSP <233> Elemental Impurities – Procedures for AnalysisUSP <39-NF34> Identification Testing of Active Pharmaceutical IngredientsUSP <41> Weights and Balances Calibration CheckUSP <467> Residual Solvents Testing in Drug SubstancesUSP <51> Antimicrobial Effectiveness Testing in Aqueous FormulationsUSP <61> Microbial Enumeration Tests for Raw MaterialsUSP <62> Tests for Specified MicroorganismsUSP <701> Disintegration Test for Uncoated TabletsUSP <711> Dissolution Testing for Immediate-Release Dosage FormsUSP <788> Particulate Matter in Injections AnalysisUSP <800> Hazardous Drugs Handling ValidationUSP <800> Surface Contamination Testing for Hazardous DrugsUSP <857> UV-Visible Spectroscopy System SuitabilityUSP <85> Bacterial Endotoxins Test for Parenteral PreparationsUSP <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

USP <1079> Good Storage and Shipping Practices for Drug Products Laboratory Testing Service

Ensuring Product Safety and Compliance

The US Pharmacopeial Convention (USP) has established a set of standards, known as the United States Pharmacopeia (USP), which serve as a benchmark for quality and purity of pharmaceutical products. One such standard is <1079> Good Storage and Shipping Practices for Drug Products, which outlines guidelines for the storage and transportation of drug products to ensure their safety and efficacy.

Relevant Standards

  • ISO 13485:2016 - Medical devices Quality management systems Requirements for regulatory purposes

  • ASTM E2501-10(2020) - Standard Guide for Thermal Analysis Techniques

  • EN 12348:2002 - Packaging of pharmaceutical products -- Flexible packaging materials -- Safety requirements

  • TSE (Turkish Standards Institution) 1239:2014 - Pharmaceutical preparations - Storage and transportation conditions

    • Legal and Regulatory Framework

    The <1079> standard is based on various regulatory requirements, including:

  • Title 21 Code of Federal Regulations (21 CFR) Part 211.160(b)(3)

  • European Unions Good Manufacturing Practice (GMP) guidelines

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7 guidelines

    • International and National Standards

    The <1079> standard is applicable worldwide, with various countries adopting similar regulations and standards:

  • USP <1079> - United States Pharmacopeia

  • ISO 13485:2016 - International Organization for Standardization

  • EN 12348:2002 - European Committee for Standardization

    • Standard Development Organizations

    The development of the <1079> standard is a collaborative effort between various organizations, including:

  • USP

  • ISO

  • ASTM

  • EN

    • These organizations continually review and update standards to ensure they remain relevant and effective.

    Evolution of Standards

    Standards evolve over time due to advances in technology, changes in regulations, or new scientific discoveries. This ensures that the <1079> standard remains current and aligned with industry needs.

    Standard Compliance Requirements

    Compliance with the <1079> standard is mandatory for pharmaceutical companies, contract manufacturers, and distributors:

  • Ensure product safety and efficacy

  • Prevent contamination and degradation

  • Maintain regulatory compliance

    • Industries and Sectors

    The <1079> standard applies to various industries and sectors, including:

  • Pharmaceuticals

  • Biotechnology

  • Medical devices

  • Contract manufacturing

    • Risk Factors and Safety Implications

    Non-compliance with the <1079> standard can result in:

  • Product recalls

  • Loss of business and reputation

  • Regulatory penalties

    • Quality Assurance and Quality Control

    The <1079> standard emphasizes the importance of quality assurance and control measures, including:

  • Calibration and validation procedures

  • Record-keeping and documentation

  • Training and certification programs

    • Contribution to Product Safety and Reliability

    The <1079> standard contributes significantly to product safety and reliability by ensuring that products are stored and transported under controlled conditions.

    Competitive Advantages

    Compliance with the <1079> standard provides competitive advantages, including:

  • Improved reputation

  • Enhanced regulatory compliance

  • Increased customer confidence

    • Cost-Benefit Analysis

    The cost-benefit analysis of implementing the <1079> standard is positive, as it:

  • Prevents product recalls and losses

  • Reduces regulatory penalties and fines

  • Enhances business reputation and competitiveness

    • ---

    Why This Test Is Needed and Required

    The USP <1079> Good Storage and Shipping Practices for Drug Products laboratory testing service is essential to ensure the safety, efficacy, and quality of pharmaceutical products.

    Business and Technical Reasons

    This test is required due to:

  • Regulatory requirements

  • Industry standards

  • Consumer protection

    • Consequences of Not Performing This Test

    Non-compliance with the <1079> standard can result in:

  • Product recalls

  • Loss of business and reputation

  • Regulatory penalties

    • Industries and Sectors That Require This Testing

    The following industries and sectors require this testing:

  • Pharmaceuticals

  • Biotechnology

  • Medical devices

  • Contract manufacturing

    • Risk Factors and Safety Implications

    Non-compliance with the <1079> standard can result in:

  • Product contamination

  • Degradation of active ingredients

  • Loss of product efficacy

    • Quality Assurance and Quality Control Aspects

    This test is essential for ensuring quality assurance and control measures, including:

  • Calibration and validation procedures

  • Record-keeping and documentation

  • Training and certification programs

    • Contribution to Product Safety and Reliability

    The <1079> standard contributes significantly to product safety and reliability by ensuring that products are stored and transported under controlled conditions.

    Competitive Advantages

    Compliance with the <1079> standard provides competitive advantages, including:

  • Improved reputation

  • Enhanced regulatory compliance

  • Increased customer confidence

    • ---

    Cost-Benefit Analysis

    The cost-benefit analysis of implementing the <1079> standard is positive, as it:

  • Prevents product recalls and losses

  • Reduces regulatory penalties and fines

  • Enhances business reputation and competitiveness

    • ---

    Ensuring Product Safety and Compliance

    This laboratory testing service is designed to ensure compliance with the USP <1079> standard, which outlines guidelines for the storage and transportation of drug products.

    Scope of Services

    Our laboratory provides a comprehensive range of services, including:

  • Temperature monitoring

  • Humidity control

  • Packaging inspection

    • Methodology

    Our team uses state-of-the-art equipment and techniques to ensure accurate and reliable results. The methodology includes:

  • Calibration and validation procedures

  • Record-keeping and documentation

  • Training and certification programs

    • Equipment and Supplies

    We use high-quality equipment and supplies, including:

  • Temperature monitoring devices

  • Humidity control systems

  • Packaging inspection tools

    • Quality Control Measures

    Our laboratory has implemented robust quality control measures to ensure accuracy and reliability of results. These include:

  • Calibration and validation procedures

  • Record-keeping and documentation

  • Training and certification programs

    • Turnaround Time

    We offer fast turnaround times, typically within 24 hours, ensuring that clients can make informed decisions promptly.

    ---

    In conclusion, the USP <1079> Good Storage and Shipping Practices for Drug Products laboratory testing service is essential to ensure compliance with regulatory requirements and industry standards. Our comprehensive range of services ensures accuracy and reliability of results, while our robust quality control measures guarantee client satisfaction.

    We hope this guide has provided valuable insights into the importance of complying with the <1079> standard. If you have any further questions or require assistance with implementing the <1079> standard, please do not hesitate to contact us.

    ---

    Additional Resources and References

    For further information on the USP <1079> standard, please consult the following resources:

  • USP website: www.usp.org(http://www.usp.org)

  • ISO 13485:2016 - Medical devices Quality management systems Requirements for regulatory purposes

  • ASTM E2501-10(2020) - Standard Guide for Thermal Analysis Techniques

  • EN 12348:2002 - Packaging of pharmaceutical products -- Flexible packaging materials -- Safety requirements

    • Glossary

  • USP <1079> standard: Guidelines for the storage and transportation of drug products.

  • Calibration: The process of adjusting equipment to ensure accuracy.

  • Validation: The process of verifying that equipment is functioning correctly.

    • ---

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